Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

NCT01593332 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-05-08

No results posted yet for this study

Summary

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.

Conditions

  • DMARD Resistant Rheumatoid Arthritis

Interventions

DRUG

Rituximab

two 500 mg rituximab infusions 2 weeks apart

DRUG

Rituximab

500mg,two times with two weeks interval

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY
  • Mashhad University of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Iran

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593332 on ClinicalTrials.gov